Identity
- Trade Name
- Palm Injector FDA UDI
- Generic Name
- Manual contrast medium injection system FDA UDI
- Device Name
- Injection Handle with 10cc Syringe FDA UDI
- Model / Reference
- H-110 FDA UDI
- Description
- Injection Handle with 10cc Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915118181 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Manual contrast medium injection system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual contrast medium injection system
Palm Injector by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual contrast medium injection system.
- Medex — ICU MEDICAL, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- LeverEdge Contrast Injector — LeMaitre Vascular, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 38146b1b-b0f8-4407-8b9b-dc9fd910eef6 34 fields · synced May 30, 2026